Randomized phase II study of concurrent and sequential combinations of rituximab plus CHOP (cyclophosphamide, doxorubicin, vincristine and prednisolone) chemotherapy in untreated indolent B-cell non-Hodgkin lymphoma: 7-year follow-up results.

Abstract

Rituximab plus cyclophosphamide, doxorubicin, vincristine and prednisolone (R-CHOP) is one of the most frequently applied initial treatments for indolent B-cell non-Hodgkin lymphoma (B-NHL); however, information on its long-term outcome is limited. Untreated patients in the concurrent arm (Arm C) received six R (375 mg/m(2) ) treatments, 2 days prior to each cycle of CHOP, and patients in the sequential arm (Arm S) received 6 weekly R (375 mg/m(2) ) treatments following six cycles of CHOP. Sixty-nine patients were randomized but two patients were withdrawn before receiving the protocol treatment. Sixty-five patients (94%) had follicular lymphoma, and 37 (55%) were at low risk, 23 (34%) at intermediate risk and seven (10%) at high risk according to the Follicular Lymphoma International Prognostic Index. We previously reported that the overall response rate (ORR) in Arm C and in Arm S was 94% and 97%, respectively. The median progression-free survival (PFS)/7-year PFS rate in Arm C, Arm S and all 67 assessable patients was 2.4 years/23% (95% confidence interval [CI], 9-40%), 3.8 years/41% (95% CI, 23-57%) and 2.8 years/32% (95% CI, 20-45%), respectively. There was no significant difference between the two arms (P = 0.107). The overall survival (OS) of the 67 patients was 95% at 7 years. In conclusion, R-CHOP is a highly effective initial treatment for untreated indolent B-NHL in terms of ORR and OS; however, its long-term PFS is not good enough either in concurrent or sequential combination, warranting further investigations on post-remission therapy.

• Authors: Kensei Tobinai, Michinori Ogura, Kuniaki Itoh, Tomohiro Kinoshita, Tomomitsu Hotta, Takashi Watanabe, Yasuo Morishima, Tadahiko Igarashi, Takashi Terauchi, Yasuo Ohashi, All Collaborators of the IDEC-C2B8 Study Group in Japan
• Journal: Cancer science (Cancer Sci) Vol. 101 Issue 12 Pg. 2579-85 (Dec 2010) ISSN: 1349-7006 [Electronic] England
• PMID: 20942866 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © 2010 Japanese Cancer Association.

Chemical References

• Antibodies, Monoclonal, Murine-Derived
• Rituximab
• Vincristine
• Doxorubicin
• Cyclophosphamide
• Prednisone

Topics

• Adult
• Aged
• Antibodies, Monoclonal, Murine-Derived (administration & dosage, adverse effects, therapeutic use)
• Antineoplastic Combined Chemotherapy Protocols (administration & dosage, adverse effects, therapeutic use)
• Cyclophosphamide (administration & dosage, adverse effects, therapeutic use)
• Disease-Free Survival
• Doxorubicin (administration & dosage, adverse effects, therapeutic use)
• Female
• Follow-Up Studies
• Humans
• Kaplan-Meier Estimate
• Lymphoma, B-Cell (drug therapy, mortality)
• Male
• Middle Aged
• Prednisone (administration & dosage, adverse effects, therapeutic use)
• Rituximab
• Treatment Outcome
• Vincristine (administration & dosage, adverse effects, therapeutic use)